Improved Patient Safety

Highlights of Other Initiatives

Presenters: Jerry Phillips, R.Ph., Associate Director for Medication Error Prevention, Food and Drug Administration. Jill Rosenthal, M.P.H., Committee on Data Standards for Patient Safety, Institute of Medicine. Laura Blum, National Quality Forum. C. Stephen Redhead, Congressional Research Service.

In addition to AHRQ's efforts in the area of patient safety, there are a number of other important activities and initiatives underway at the national level. The following activities were highlighted at the workshop:

• The Federal Food and Drug Administration (FDA) is pursuing a number of initiatives intended to reduce medication errors and improve patient safety. Jerry Phillips highlighted several of these efforts, including:
  1. The proposed rule requiring bar coding on pharmaceutical, biological and blood product labeling be enacted in spring 2004.
  2. The Health Collaborative Network allows the FDA to receive data on actual and potential adverse drug events from health care providers using electronic medical records and standardized reports.
  3. The FDA Patient Safety News broadcasts a monthly 15 minute video news show that highlights recent approvals, product recalls, safety alerts, and information on preventing medication errors and protecting patients (http://www.fda.gov/psn).
• With support from AHRQ, the IOM established a committee to develop standards for the collection, coding and classification of information on patient safety errors. Jill Rosenthal, a member of the Patient Safety Data Standards Committee, gave an overview of the Committee's deliberations, emphasizing that the goal of the Committee's work is to offer recommendations that will help States to collect comparable data and make valuable comparisons among providers and hospitals and between States. In addition to considering the data requirements for safe care and stakeholders' roles, the Committee also explored the need for and status of standard setting in data interchange, terminologies, reporting formats, and knowledge representation. The final report was released in November 2003 (http://www.iom.edu/report.asp?id=16663).
• Laura Blum described how the National Quality Forum (NQF), a national advisory organization focused on health care quality and patient safety issues, has used a consensus process to identify, adopt and release 31 health care practices and measures to standardize health care performance measures and reporting. The NQF also has identified a core set of serious adverse events that should never happen in health care. Data on the occurrence of these "never" events are valuable indicators that can be included in State patient safety reporting systems (http://www.qualityforum.org/).
• Legislation has also been introduced in Congress to address patient safety. The Congressional Research Service's Stephen Redhead discussed the provisions of HR 663 and S 720, the Patient Safety Quality Improvement Act. Introduced in the 108th Congress, these two bills are designed to encourage reporting of medical errors by certifying patient safety organizations in each State to collect data and report on medical errors. Protections from discovery are included in each bill. Neither bill appears to preempt State reporting requirements.

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